MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for BIOZORB MARKER manufactured by Focal Therapeutics (a Hologic Company).
| Report Number | 3009718212-2020-00002 |
| MDR Report Key | 9860362 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GEORGE MARCEL |
| Manufacturer Street | 1010 STEWART DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 9627003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOZORB MARKER |
| Generic Name | MARKER, RADIOGRAPHIC, IMPLANTABLE |
| Product Code | NEU |
| Date Received | 2020-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCAL THERAPEUTICS (A HOLOGIC COMPANY) |
| Manufacturer Address | SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |